Influenza ANCT02487173
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
A study testing Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) in people with Influenza A and Influenza B, run by Ellume Pty Ltd at 4 sites in Australia.
Trial summary
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Influenza A, Influenza B
- What is being tested?
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 4 sitesAustralia
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects aged ≥ 1 year;
- Rhinorrhea;
- ≤ 72 hours from onset of Influenza-like illness symptoms;
- Subject (or parent/legal guardian) capable and willing to give informed consent/assent.
- Subject (or parent/legal guardian) able to read and write in English.
Who cannot join
- Has undergone treatment with antivirals within the previous 7 days;
- Has been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
- Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
- Has had prior exposure to the Respirio Flu Test;
- Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Taringa 7 Day Medical Practice
Brisbane, Queensland, 4068
Graceville Medical
Brisbane, Queensland, 4075
Inala Primary Care
Brisbane, Queensland, 4077
Limestone Medical Centre
Ipswich, Queensland, 4305
About this study
Official title: A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
The secondary aims are to:
- validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
- evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
- evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
- evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
- establish the minimum sample weight required to achieve a result with the Respirio Flu Test.
- Conditions
- Influenza A, Influenza B
- Being tested
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respirio Flu TestDevice
The Respirio Flu Test is a rapid test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Device
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse-transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
Sofia® Influenza A+B Fluorescent Immunoassay (FIA)Device
Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients.
| Study group | Role | What they receive |
|---|---|---|
| Respirio Flu Test | Experimental | Upper respiratory tract samples from participants will be tested with:
* Respirio Flu Test
* Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
* Sofia® Influenza A+B Fluorescent Immunoassay (FIA) Receives: Device: Respirio Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Device: Sofia® Influenza A+B Fluorescent Immunoassay (FIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Of participants positive for influenza A by ReverseTranscriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Secondary outcomes (9)
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.
Establish positive agreement against an imperfect standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.
Establish negative agreement against an imperfect standard. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Percent of participants who correctly interpret result of Respirio Flu Test.
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
The ease of use questionnaire will provide the following:
- Total number of responses to each question and the percentage of participants selecting each response (most on a 5 point Likert scale).
Measured: Day 1
Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.
The label comprehension questionnaire will provide the following data
- Total number of responses to the question and the percentage of participants selecting each option.
- Number and percentage of participants selecting the correct answer to each question.
- Overall percentage of patients with an acceptable level of comprehension.
Measured: Day 1
Weight of sample deposited in Respirio Flu Test.
Establish minimum weight of sample required to obtain a valid result from the Respirio Flu Test.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellume Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487173
- Sponsor's protocol ID
- RESP15001
- Status last verified
- Jul 2016
- First submitted
- 26 Jun 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B
- ClinicalTrials.gov ID
- NCT02487173
- Acronym / sponsor ID
- RESP15001
- Conditions
- Influenza A, Influenza B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ellume Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
The secondary aims are to:
- validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
- assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
- evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
- evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
- evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
- establish the minimum sample weight required to achieve a result with the Respirio Flu Test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respirio Flu Test | Experimental | Device: Respirio Flu Test, Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Device: Sofia® Influenza A+B Fluorescent Immunoassay (FIA)Upper respiratory tract samples from participants will be tested with: * Respirio Flu Test * Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) * Sofia® Influenza A+B Fluorescent Immunoassay (FIA) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged ≥ 1 year;
- Rhinorrhea;
- ≤ 72 hours from onset of Influenza-like illness symptoms;
- Subject (or parent/legal guardian) capable and willing to give informed consent/assent.
- Subject (or parent/legal guardian) able to read and write in English.
Key exclusion criteria (6 listed)
- Has undergone treatment with antivirals within the previous 7 days;
- Has been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
- Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
- Has had prior exposure to the Respirio Flu Test;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respirio Flu TestThe Respirio Flu Test is a rapid test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes. | Device | Respirio Flu Test |
| Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse-transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected. | Device | Respirio Flu Test |
| Sofia® Influenza A+B Fluorescent Immunoassay (FIA)Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients. | Device | Respirio Flu Test |
Primary outcome
Of participants positive for influenza A by ReverseTranscriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Time frame: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.
Time frame: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
9 secondary outcomes
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test.
Time frame: Day 1
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test.
Time frame: Day 1
Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.
Time frame: Day 1
Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.
Time frame: Day 1
Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% confidence limits.
Time frame: Day 1
Percent of participants who correctly interpret result of Respirio Flu Test.
Time frame: Day 1
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
Time frame: Day 1
Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.
Time frame: Day 1
Weight of sample deposited in Respirio Flu Test.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) in people with Influenza A and Influenza B, run by Ellume Pty Ltd at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Of participants positive for influenza A by ReverseTranscriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016.